Registration Dossier
Registration Dossier
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EC number: 402-140-1 | CAS number: 17865-32-6 CHMMS; CHMS; DYNASYLAN 9407; Z-6187
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05.07.1995 to 09.07.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEc, Method B5
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cyclohexyldimethoxymethylsilane
- EC Number:
- 402-140-1
- EC Name:
- Cyclohexyldimethoxymethylsilane
- Cas Number:
- 17865-32-6
- Molecular formula:
- C9H20O2Si
- IUPAC Name:
- cyclohexyldimethoxymethylsilane
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.7-2.92 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 49-68
- Air changes (per hr): Approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 05.07.1995 To: 09.07.1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- N/A
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- One initially, then an additional two
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: examination was facilitated using the light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No corneal effects noted. Iridial inflammation noted in one treated eye at 24 hours, but no other iridial effects noted. Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment and in two treated eyes at the 24-hour observation. Minimal conjunctival redness persisted in one treated eye at the 48-hour observation. Changes fully reversible within 72 hours.
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In an eye irritation study conducted according to OECD Test Guideline 405 and in compliance with GLP (reliability score 1) cyclohexyldimethoxymethylsilane was not irritating to the eyes of rabbits.
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